Active ingredient
- amlodipine besilate
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0235.
Amlodipine 2mg/ml Oral Solution
Package Leaflet: Information for the user
Amlodipine 2mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Amlodipine Oral Solution is and what it is used for
2. What you need to know before you take Amlodipine Oral Solution
3. How to take Amlodipine Oral Solution
4. Possible side effects
5. How to store Amlodipine Oral Solution
6. Contents of the pack and other information
1. What Amlodipine Oral Solution is and what it is used for
The name of your medicine is Amlodipine 2mg/ml Oral Solution (called Amlodipine in this leaflet). Amlodipine belongs to a group of medicines called calcium antagonists.
Amlodipine is used to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.
In patients with high blood pressure your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. Your medicine does not provide immediate relief of chest pain from angina.
2. What you need to know before you take Amlodipine Oral Solution
Do not take Amlodipine if:
Warnings and precautions
Talk to your doctor or pharmacist before taking Amlodipine.
You should inform your doctor if you have or have had any of the following conditions:
Children and adolescents
Amlodipine has not been studied in children under the age of 6 years. Amlodipine should only be used for hypertension in children and adolescents from 6 years to 17 years of age (see section 3).
For more information, talk to your doctor.
Other medicines and Amlodipine
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Amlodipine may affect or be affected by other medicines, such as:
Amlodipine may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.
Amlodipine with food and drink
Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine.
Pregnancy
Breast-feeding
Driving and using machines
Amlodipine may affect your ability to drive or use machines. If this medicine makes you feel sick, dizzy or tired, or gives you a headache, do not drive or use machines and contact your doctor immediately.
Amlodipine Oral Solution contains liquid maltitol and glycerol.
3. How to take Amlodipine Oral Solution
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
Measuring your dose using the oral syringe provided
Instructions for use
Taking this medicine via NG or PEG tubes
1. Ensure the tube is clear before taking the medicine
2. Flush the tube with the minimum volume of water required.
3. Administer the medicine with a suitable measuring device, which will be provided by your doctor, pharmacist or nurse. Do not use the oral syringe provided in the pack.
4. Flush the tube again with the minimum volume of water.
Adults
The usual initial dose of Amlodipine is 5mg (2.5ml) once daily. The dose can be increased to 10mg (5ml) once daily.
Use in children and adolescents
For children and adolescents (6-17 years old), the recommended usual starting dose is 2.5mg (1.25ml) a day. The maximum recommended dose is 5mg (2.5ml) a day.
It is important to keep taking this medicine. Do not wait until you have finished this medicine before seeing your doctor.
If you take more Amlodipine than you should
Taking too much medicine may cause your blood pressure to become low or even dangerously low.
You may feel dizzy, lightheaded, faint or weak. If the blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too much medicine.
If you forget to take Amlodipine
If you stop taking Amlodipine
Your doctor will advise you how long to take your medicine.
Your condition may return if you stop using your medicine before you are advised.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Amlodipine can cause side effects although not everybody gets them.
Visit your doctor immediately if you experience any of the following very rare, severe side effects after taking this medicine.
The following very common side effect has been reported. If this causes you problems or if it lasts for more than one week, you should contact your doctor.
Very common: may affect more than 1 in 10 people
The following common side-effects have been reported. If any of these cause you problems or if they last for more than one week, you should contact your doctor.
Common: affects 1 to 10 users in 100
Other side-effects that have been reported include the following list. If any of these get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. How to store Amlodipine Oral Solution
6. Contents of the pack and other information
What Amlodipine Oral Solution contains
What Amlodipine Oral Solution looks like and contents of the pack
Your medicine is a clear, pale straw coloured viscous liquid.
It comes in a brown glass bottle holding 150ml of solution with a 5ml purple oral syringe and adaptor.
Marketing Authorisation Holder and Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
UK, Ireland – Amlodipine 2mg/ml Oral Solution
France - Amlodipine Cevidra 2 mg/ml, solution buvable
This leaflet was last revised in 05/2021
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